Category: 3. Business

The ACCC has commenced separate proceedings in the Federal Court against home meal delivery providers Grocery Delivery E-Services Australia Pty Ltd (trading as HelloFresh) and Youfoodz Pty Ltd for allegedly misleading consumers over subscriptions.

The ACCC alleges that HelloFresh and Youfoodz, which are both owned by HelloFresh SE, breached the Australian Consumer Law by advertising on their websites and apps that new customers could easily cancel subscriptions through their online account settings as long as they did so before a specified cut-off time. In fact, when many consumers tried to cancel their subscription online prior to the first delivery cut-off time, they were still charged for and received the first order.

Despite being able to sign up easily through the websites and apps, consumers were only able to cancel the first delivery if they spoke with a customer service representative.

HelloFresh allegedly carried out this conduct between 1 January 2023 and 14 March 2025, and Youfoodz between 1 October 2022 and 22 November 2024. During these periods, 62,061 HelloFresh customers and 39,408 Youfoodz customers were charged a fee despite cancelling their subscription before the specified cut-off time for the first order.

“We’ve brought these two cases because we allege that HelloFresh’s and Youfoodz’s conduct involved a suite of confusing and unclear subscription practices in breach Australia’s consumer laws,” ACCC Commissioner Luke Woodward said. 

“Despite what HelloFresh and Youfoodz represented to new Australian subscribers, tens of thousands of consumers were charged for their first order, even though they cancelled their subscription before the cut-off date.”

The ACCC also alleges that HelloFresh required consumers to provide payment details to view and select meals from the full menu but represented to them in the sign-up process that they would not be charged unless they selected meals from the menu. In fact, when consumers clicked the button to progress to the meal selection screens, they were entered into an ongoing subscription and charged for the first delivery.

Many HelloFresh consumers were not even aware that they had been signed up to an ongoing subscription until they received a delivery or payment notification.

The ACCC also alleges that Youfoodz communicated to consumers who had taken steps to cancel their subscription in their online account settings that the first delivery was cancelled and they would not be charged, when in fact the first delivery could not be cancelled this way and they were still charged.

“In the case of HelloFresh, many consumers had not even selected meals but were unknowingly subscribed and charged regardless,” Mr Woodward said.

“Traders must clearly communicate when consumers are signing up for a subscription, as well as how they are able to cancel and avoid being charged.”

“Businesses using confusing and complicated subscription cancellation policies is a matter of significant public concern and, where there is evidence of breaches of the Australian Consumer Law and consumer harm, the ACCC will take enforcement action when appropriate,” Mr Woodward said.

“We are also urging consumers who are purchasing gifts this festive season to carefully review the contract terms before paying for any subscriptions.”

Consumer and fair trading issues in the digital economy and in the supermarket and retail sectors are among the ACCC’s current 2025-26 Enforcement Priorities.

The ACCC is seeking compensation orders for affected consumers, penalties, declarations, publication orders, the implementation of a compliance program and costs.

Individual consumer experiences

In one example, a consumer accessed the HelloFresh website on their phone and entered their payment details to view the menu, but after viewing it, decided not to proceed with a subscription. They did not realise that by saving their payment details, they were already subscribed. They later received a notification via PayPal that they had been charged and found it difficult to contact HelloFresh regarding the payment at a time when they were experiencing financial distress.

In another case, a consumer signed up for a Youfoodz subscription, which they cancelled online within minutes of viewing the menu. They later received a text stating their delivery would arrive the following day and they had been charged. They called Youfoodz multiple times to request a refund and were eventually offered a 50 per cent refund.

Background

HelloFresh and Youfoodz are both owned by the German-based parent company HelloFresh SE. HelloFresh offers weekly meal kits, whereas Youfoodz offers weekly ready-made meals.  

Consumers can sign up for HelloFresh’s or Youfoodz’s services through their websites or their smartphone applications.

The ACCC commenced its investigation into HelloFresh and Youfoodz in October 2024 after receiving a large number of consumer complaints.

Concise statements

ACCC v HelloFresh Concise Statement 16 December 2025

( PDF 534.99 KB )

ACCC v Youfoodz Concise Statement 16 December 2025

( PDF 538.64 KB )

Part I: The digitised grid

Introduction

In recent years, Australia has become a world leader in distributed energy resources (DER) and consumer energy resources (CER)[1], with many households and small businesses generating power through rooftop solar, battery storage and electric vehicles.[2]

At the same time, the growing number of connected devices has expanded the potential entry points for cyberattacks.[3] As operational technology (OT) and information technology (IT) become more integrated, the grid faces increased exposure to cyberwarfare and ransomware. Hackers may target the grid for financial gain, disruption of critical infrastructure or to access sensitive information. Breaches could interrupt electricity supply, cause widespread blackouts and destabilise essential services such as telecommunications, transport and water systems.

Protecting the grid is therefore a priority. Australia must implement robust IT and OT security measures, enhance its regulatory frameworks, ensure vendors maintain full visibility and control of connected systems and foster cooperation between government, industry and cybersecurity experts to safeguard critical infrastructure.[4]

How has Australia’s grid become more digitised?

Across Australia, the energy landscape is undergoing rapid change. Projections indicate that by 2050 almost half of all households and businesses will operate rooftop solar systems, with approximately 61% – 84% of rooftop solar systems expected to be coupled with a battery as uptake increases.[5]

Integrating these variable energy sources into the grid is challenging and can result in grid constraints and power inefficiencies if not done effectively.[6]

Grid digitisation involves integrating information and communication technologies (ICT) and advanced data analytics into the electricity network to improve efficiency, reliability and security.[7]

Notably, Australia’s renewable energy industry has been transformed by:

1. The ‘Internet of Things’ (IoT): In the renewable energy context, is a network of interconnected devices (such as smart meters, solar inverters, wind turbine sensors, batteries and electric vehicle chargers) that collect and exchange real-time data to optimise energy production, storage and use. IoT enables operators to monitor equipment performance, forecast generation, balance supply and demand and detect faults early. At the household level, IoT supports ‘smart’ energy use by automatically running appliances based on solar output or off-peak times, forming the foundation for technologies like smart grids and energy management systems.[8]
2. Smart grid technology: A digitised network that uses data analytics, sensors and automated control systems to manage electricity flows in real-time.[9] This allows the grid to respond dynamically to fluctuations in supply and demand, integrate DER more effectively and provide greater visibility for both operators and consumers.
3. Energy management software (EMS): Cloud-based systems that monitor and control DER to optimise energy use.[10] In homes, EMS platforms decide when to charge or discharge batteries or draw from the grid to minimise costs.[11] In commercial settings, they provide centralised, real-time oversight of energy performance across sites, often integrating with building management systems to manage temperature, ventilation, and lighting.

However, whilst these innovations help bridge the gap between OT and IT, the increased connectivity of devices and systems (which were previously more isolated)[12] also brings new vulnerabilities, fuelling an increase in concerns around data protection and cybersecurity.

 

The harm with digitisation

How digitisation increases risk

As society’s dependence on digitally connected renewable energy infrastructure grows and more automation is introduced to manage the grid’s increasing complexities, vulnerability to cyberattacks rises. Each new connection introduces potential weaknesses, increasing the risk of compromised security and large-scale disruption.[13]

The rapid uptake of solar and smart energy appliances in homes and businesses has expanded potential entry points for cyberattacks, [14] with connected devices varying widely in their levels of security. [15]

Because the renewable energy sector underpins both national infrastructure and the broader economy, a single cyber incident or technical failure could disrupt electricity supply, compromise critical infrastructure, weaken grid stability and (in severe cases) destabilise entire regions. [16]

Cybersecurity experts warn that as systems become more interconnected, cybersecurity becomes even more critical.[17] Our energy networks, and by extension, modern life, depend on secure, uninterrupted access to power.[18]

Consequently, cybersecurity is not just about protecting digital assets but about safeguarding the stability of the national energy system itself.^[19] Continuous monitoring, validation, and authentication across all devices and users are essential to maintaining that security.[20]

 

Types of threats hackers can carry out

Over the past year, cyberattacks on the energy, transport and telecommunications sector have increased by 30%.[21] In 2023 alone, 90% of the world’s largest energy companies suffered a cybersecurity breach.[22]

There are various types of threats to DERs and that may be carried out by hackers, including:

1. Social engineering attacks: Hackers use phishing emails, fake websites, or messages to trick employees, installers, or consumers into revealing passwords or system access credentials, potentially allowing unauthorised control of solar inverters, batteries, or management platforms.[23]
2. Malware-based attacks: Malicious software such as ransomware or trojans can infiltrate energy management systems or IoT devices, disrupting operations, encrypting control data, or remotely manipulating device settings to destabilise local grids or virtual power plants.[24]
3. Supply chain compromises: Attackers may target trusted vendors, installers, or software providers, injecting malware into firmware updates or compromising third-party integrations, to gain indirect access to multiple DER systems simultaneously.[25]

An example of how these threats could affect DER is through smart meters or home energy management systems. If an attacker manipulates DER telemetry or control signals (such as coordinating rapid, periodic changes in battery charge/discharge or photovoltaic output) it could mimic an oscillation attack, destabilising local voltage or frequency. Grid protection systems may then trip automatically, potentially causing localised blackouts or disrupting aggregated DER services like virtual power plants.[26]

As security systems strengthen, cybercriminals are becoming increasingly sophisticated,[27] exploiting gaps between IT and OT (with the latter historically being less developed and protected). With IT and OT now more integrated, companies are adopting software solutions to properly safeguard OT, identify grid bottlenecks and mitigate these emerging cyber risks. [28]

Part II: Cyber resilience and regulation

Current regulatory landscape

Regulatory frameworks and gaps

Australia’s current protections for DER are delivered through a combination of the below key sector-led guidance and legislative frameworks.

Two new legal frameworks were recently passed that focus specifically on CERs. Whilst CERs form a substantial component of DERs, the two are not identical, with DERs being broader in scope. Not all measures and protections that apply to CERs will extend to DERs more generally.

2. Cyber Security Act 2024 (Cth) (Cyber Act):[29]
   Enacted on 29 November 2024, the Cyber Act strengthens CER protections by requiring smart energy devices, including inverters and battery systems, to meet minimum cybersecurity standards. It also mandates reporting ransom or extortion incidents within 72 hours and establishes a Cyber Incident Review Board to assess major incidents and issue sector-wide recommendations. These reforms directly target vulnerabilities at the device level and are expected to influence the broader DER ecosystem as smart devices proliferate.
3. Cyber Security (Security Standards for Smart Devices) Rules 2025 (Cyber Rules):[30]
   Effective 4 March 2026, the Cyber Rules set a mandatory baseline for consumer-grade internet-connected devices, including CER. Requirements include unique passwords, security contact points, and defined update periods. By addressing these common vulnerabilities like default passwords and inconsistent updates, the Cyber Rules enhance CER security, privacy, and reliability while indirectly strengthening protections for the wider energy network into which DERs integrate.

The above CER-specific frameworks sit alongside the following broader DER-relevant mechanisms:

1. Updates to the National Electricity Rules (NER)
   In December 2024, the Australian Energy Market Commission introduced a rule clarifying the Australian Energy market Operator’s (AEMO) cybersecurity role, formalising four functions: coordinating incidents, supporting preparedness via AESCSF and exercises, advising government and industry on risks, and sharing critical cybersecurity information with market participants.[31]
2. Australian Energy Sector Cyber Security Framework (AESCSF)
   The AESCSF is a cybersecurity framework developed and tailored to the Australian energy sector, enabling market and non-market participants (including DER participants), to assess, evaluate, prioritise, and improve their cybersecurity capability and maturity.[32]The AESCSF Lite Framework provides a customised approach for smaller, emerging, or resource-constrained organisations, including those operating within the DER ecosystem.[33] These organisations play a vital role in the broader energy landscape and are increasingly interconnected with critical energy systems. The framework is deliberately designed to be agnostic to organisational size, scale, or maturity, making it more suited for DER participants that may lack dedicated cybersecurity teams or fully developed security programmes.[34]
3. Security of Critical Infrastructure Act 2018 (SOCI Act)
   The amended SOCI Act broadened its scope to include the energy sector, introducing stringent cybersecurity standards and incident reporting obligations for energy providers. Under the SOCI Act, owners and operators of ‘critical infrastructure’ face fines and penalties if they fail to meet prescribed security requirements.[35]

However, despite these frameworks, DER presents unique vulnerabilities. Except for the Cyber Act and Cyber Rules (which are more relevant for CERs), most of the above frameworks[36] largely focus on aggregated or centrally registered assets, leaving gaps for behind-the-meter DER. Key observations made by industry stakeholders include:

1. The SOCI Act excludes generators with a capacity under 30 MW and lacks a clear classification for DER aggregators (which may control capacities above this threshold), creating uncertainty about which obligations apply to original equipment manufacturers (OEMs).[37]
2. Some distribution network service providers (DNSPs) have introduced their own guidelines for how SOCI Act requirements apply to DER and OEMs, but SMA and the Smart Energy Council note this can lead to inconsistencies and potential misunderstandings across jurisdictions.[38]
3. The AESCSF does not cover device-level standards for products such as inverters, and the new NER, which formalised AEMO’s cybersecurity role, does not give AEMO authority to mandate participation, leaving OEMs guided by generators’ requirements, which may include SOCI Act obligations.^[39]

Although cyber regulation and policies exist, it can be difficult for consumers to find out how these requirements are enforced and reported.[40] Stakeholders have called for a national, DER cybersecurity strategy, clearer guidance from market bodies and governments on DER security, and the introduction of mandatory standards for DER systems.[41] Whilst stakeholders have welcomed the emerging CER-specific protections, it is noted that these measures are still in early stages[42] and further clarity is needed from market bodies and governments on the practical application of these requirements.[43]

 

Current technology and gaps

Australia’s DER systems employ multiple layers of cybersecurity to protect renewable energy assets.[44]

At a high level, operators use encrypted communications, multi-factor authentication, network segmentation, automated threat detection, and AI driven anomaly monitoring, often supported by 24/7 Security Operations Centres. Frameworks such as the AESCSF help DER providers conduct risk checks, vet vendors, and plan incident responses.[45] Device-level systems, such as microgrid controllers and inverters, use layered security including firewalls, encryption, and intrusion detection.[46] Initiatives like South Australia’s Virtual Power Plant security framework provide real-time monitoring and active protection across DER networks.[47]

Despite these measures, DER systems remain vulnerable to attack. Internet-connected inverters, batteries, and other DER devices are still exposed to data attacks, operational disruption, or grid instability,[48] increasing the volume of sensitive data at risk.[49] Diverse technologies, multiple stakeholders, and mixed old and new systems makes consistent protection challenging.[50] Stand-alone security solutions often fail to detect risks across interconnected DER assets, while operators and utilities may lack access to sufficient operational data to respond quickly, leaving gaps similar to those seen in consumer-grade smart devices.

 

Future directions for DER cybersecurity

Preventing attacks is not the responsibility of a single group. Close cooperation between all industry players is essential to building a robust defence,[51] ensuring the responsibility for protection does not fall entirely on households and small businesses. For owners of DER, practical steps such as maintaining a secure home Wi-Fi network and using strong, unique passwords can provide an added layer of protection.[52]

The industry should consider the following initiatives to strengthen DER cybersecurity:

1. Close regulatory gaps and harmonise frameworks: Address the SOCI Act’s 30 MW threshold and implement a national strategy to align requirements across jurisdictions and DNSPs.[53]
2. Introduce mandatory device-level standards across all DERs: Require mandatory security standards across all DERs (rather than only focusing on regulation at the CER level and relying on voluntary frameworks for broader DERs) for inverters, smart meters, and communications gateways, including proactive safeguards, vulnerability testing,[54] secure procurement, multi-factor authentication, network segmentation, and timely intelligence sharing with AEMO and regulators.[55]
3. Ensure supply chain accountability: Provide clear guidance on how cybersecurity obligations flow through the DER supply chain, from OEMs to service providers to end users, recognising that overall security is only as strong as the weakest link, with IoT and AI creating additional risks.[56]
4. Enhance AEMO resourcing and preparedness: Expand AEMO’s role in risk assessment, threat intelligence dissemination, and proactive guidance to improve DER resilience.[57]
5. Adopt a prescriptive regulatory approach: Stronger and more integrated regulatory measures are needed to address the current fragmented framework and better safeguard Australia’s evolving energy ecosystem.[58]

 

Conclusion

Australia’s shift to a decentralised, digitally connected energy grid has made it a global leader in DER, delivering sustainability, efficiency, and energy independence. However, increased IT/OT integration has expanded the cyberattack surface, where vulnerabilities in one area can have widespread effects.

Mitigating these risks requires a coordinated approach: strengthening IT and OT protections, maintaining visibility and control over infrastructure, and regularly testing and updating cybersecurity measures. Collaboration between government, industry, specialists, and consumers ensures shared responsibility. By combining technological safeguards with coordinated policy and active risk management, Australia can grow its clean energy capabilities while protecting critical infrastructure from emerging cyber threats.

 

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The Hamilton Locke team advises across the energy project life cycle – from project development, grid connection, financing, and construction, including the buying and selling of development and operating projects. For more information, please contact Matt Baumgurtel.

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[1] CERs are a subset of DERs and specifically refer to the consumer-owned technologies which generate, store or manage electricity. The primary focus of this article is on DERs.

[2] Michael Rothschild, ‘Combating the cyber threat to Australia’s distributed solar grid ambitions’ Australian Information Security Association (Web Page) .

[3] Daniel Mercer, ‘Australia’s electricity grid increasingly vulnerable to hackers via solar panels, smart devices’, ABC News (online, 14 March 2022) .

[4] Rothschild (n 2).

[5] Green Energy Markets, Projections for distributed energy resources – solar PV and stationary energy battery systems (Report, December 2024) 14 chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.aemo.com.au/-/media/files/major-publications/isp/2025/GEM-2024-Solar-PV-and-Battery-Projections-Report.pdf>.  

[6] ‘Role of Smart Grids in Australia’s Path to Energy Independence’ Smart Lifestyle Australia  (Web Page, 11 February 2025) .

[7]Power Circle, Digitalization of the Grid (White Paper, November 2022) 2 .

[8] Jasmin Jessen, ‘Top 10 Uses of IoT in Energy’, Energy Digital (Web Page, 12 March 2025) ; Tanveer Ahmad and Dongdong Zhang, ‘Using the internet of things in smart energy systems and networks’ (2021) 68 Sustainable Cities and Society.

[9] Warren, Smart Grid Technology: Powering Australia’s Renewable Energy Future’ Sustainable Future Australia (Web Page, 2 April 2025) .

[10] ‘How cyber attacks can threaten the energy transition’, Twoday (Web Page, 1 September 2025) .

[11] ‘Home Energy Management System’, Evergen (Web Page) <https://evergen.energy/home-energy-management-systems/>.

[12] Warren (n 9).

[13] Mercer (n 3).

[14] Warren, ‘Renewable Energy’s Achilles Heel: Why Cybersecurity is Critical for Australia’s Green Grid’, Sustainable Future Australia (Web Page, 3 April 2025). .

[15] Mercer (n 3)

[16] Warren (n 14).

[17] Mercer (n 3).

[18] Mercer (n 3).

[19] Warren (n 14).

[20] Richard Bergman, Tony Martin and Emma Hawthorne, ‘How cyber security can keep pace with the energy transition’, EY (Web Page, 9 October 2023). .

[21] The Transformation Group, Safeguarding the grid: Cyber Threats in Energy Infrastructure (Report) 2 .

[22] ‘Securing Renewable Data: Green Energy Sector Cybersecurity Challenges’ Beetroot (Web Page, 3 May 2025) < https://beetroot.co/business/securing-renewable-data-green-energy-sector-cybersecurity-challenges/#:~:text=Renewable%20energy%20systems%2C%20from%20wind,millions%20of%20customer%20data%20records.>.

[23] ‘Cybersecurity Challenges in the Renewable Energy Sector’, EC-Council University (Web Page, 10 February 2025) .

[24] See ibid.

[25] Twoday (n 10).

[26] Falah Alanazi, Jinsub Kim and Eduardo Cotilla-Sanchez, ‘Load Oscillating Attacks of Smart Grids: Vulnerability Analysis’ (2023) 11 IEEE Access 36538, 36538-36539.

[27] CrowdStrike, 2025 Global Threat Report (Report) 2-3 .

[28] Tom Kline, Unlocking Australia’s Green Future: The Critical Rols of New Grid Technology’, Climate Tech Partners (Web Page, 28 October 2025) .

[29] Department of Home Affairs, ‘Cyber Security (Security Standards for Smart Devices) Explanatory Document’ (Explanatory Document, 2024) .

[30] See Ibid.

[31] Australian Energy Market Commission, ‘National Electricity Amendment (Cyber security roles and responsibilities) Rule 2024 (Final Determination, December 2024) 32 .

[32] Australian Energy Market Operator, ‘AESCSF 2025 Distributed & Consumer Energy Resources Guidance’ (Guidance Material, 2025) 4 .

[33] See Ibid 5-7.

[34] Australian Energy Market Operator (n 32) 7.

[35] Australian Energy Market Commission (n 31).

[36] Department of Climate Change, Energy, the Environment and Water, ‘National Consumer Energy Resources Roadmap’ (Report, July 2024) .

[37] Australian Energy Market Operator (n 32).

[38] Australian Energy Market Operator (n 32).

[39] Australian Energy Market Operator (n 32).

[40] SolarEdge, ‘Submission to the 2023-2030 Australian Cyber Security Strategy’ (Submission, 29 August 2025) 2 .

[41] Department of Climate Change, Energy, the Environment and Water (n 36).

[42] SolarEdge (n 40).

[43] Department of Climate Change, Energy, the Environment and Water, ‘National Consumer Energy Resources (CER) Roadmap Implementation Plan Update’ (Report, August 2025) 20 .

[44] Warren (n 14).

[45] Warren (n 14).

[46] Juanwei Chen et al,’ Cybersecurity of distributed energy resource systems in the smart grid: A survey’ (2025) 383 Applied Energy.

[47] Warren (n 14).

[48] Juanwei Chen et al (n 46).

[49] Juanwei Chen et al (n 46).

[50] Juanwei Chen et al (n 46).

[51] ‘OT Security: Recent Attacks Expose Risks for Australia’s Critical Infrastructure‘ KineticIt, (Web Page, 15 October 2024) .

[52] Dor Son Tan, ‘Energy System Cybersecurity for an Uncertain World’, Energy Networks Australia (Web Page, 20 April 2023) .

[53] Australian Energy Market Commission (n 31).

[54] Bella Peacock, ”Really Serious’ Problems Cybersecurity Breaches Pose in Australia’s DER Future’, PV Magazine Australia (Webpage, 27 June 2023) .

[55] Australian Energy Market Commission (n 31).

[56] Australian Energy Market Commission (n 31).

[57] Australian Energy Market Commission (n 31).

[58] Australian Energy Market Commission (n 31).

In a move aimed at tying reimbursement to patient outcomes, the Centers for Medicare & Medicaid Services (CMS) Innovation Center announced the “Advancing Chronic Care with Effective Scalable Solutions” (ACCESS) model, a 10-year demonstration project that will begin in April 2026. Unlike traditional fee-for-service structures that reward activities, ACCESS will offer participating organizations reimbursement based on whether patients achieve defined health goals – rather than on the volume of services provided. The potential to receive reimbursement for technology-enabled services via ACCESS could be a boon for telehealth and disease management companies, especially those aimed at chronic conditions, such as obesity, diabetes, chronic musculoskeletal pain and depression, that may use technology-enabled services to complement traditional care pathways.

On December 8, 2025, the Food and Drug Administration (FDA) unveiled its companion pilot program, “Technology-Enabled Meaningful Patient Outcomes” (TEMPO), which seeks to “encourage the use of digital technologies that meet people where they are.” TEMPO is a voluntary program that would enable up to 40 companies (approximately 10 for each of four program areas, namely, early cardio-kidney-metabolic conditions, cardio-kidney-metabolic conditions, musculoskeletal pain and behavioral health) to opt in to FDA’s risk-based program whereby FDA would exercise enforcement discretion with respect to certain requirements for sponsors in the program, such as premarket review requirements, before commercialization. In exchange, those enrolled in TEMPO will collect, monitor and report to FDA real-world data for how these technologies perform in practice.

Participation in TEMPO requires an initial simple step. Interested parties need to submit only a “Statement of Interest” as early as January 2, 2026, that:

1. Identifies the manufacturer and its device, including any current authorizations or prior FDA interactions related to the device or proposed indications for use.
2. Requests that FDA give the manufacturer a statement that FDA does not intend to enforce certain legal requirements, such as premarket authorization requirements, Investigational Use Device (IDE) requirements, and requirements under 21 CFR Parts 50 and 56.

In addition, the digital health devices in the TEMPO pilot must pose no serious risk to patients and be intended for clinician-supervised outpatient use. If selected, participants are expected to submit a much more onerous package to the agency in March 2026 that includes information such as device descriptions, safety data, quality management systems, risk mitigation plans, performance goals, timelines for marketing submissions and interim reporting strategies. Selected participants can also engage in “sprint” discussions with FDA to resolve specific issues within defined time frames. Importantly, participation in TEMPO does not guarantee future marketing authorization, though data generated during the pilot may support subsequent submissions.

The process for applying to ACCESS is also simple. Similar to the FDA process, to participate in ACCESS, an organization must first complete a nonbinding ACCESS Model Interest Form, followed by a full application. Although the application form has not yet been released, for the performance period beginning July 1, 2026, applications will be due by April 1, 2026.

Participation in ACCESS also requires Medicare Part B enrollment and a designated medical director to oversee care quality and compliance with applicable federal and state regulations, including licensure, Health Insurance Portability and Accountability Act (HIPAA) and privacy security, and FDA requirements. This last regulatory requirement is where ACCESS and TEMPO are meant to work together. Through TEMPO, sponsors of technology-enabled healthcare products may be able to offer their technology under the TEMPO program’s enforcement discretion policies to participants in the ACCESS model, which may be eligible to receive reimbursement for those technology-enabled services through ACCESS.

Key considerations before applying to ACCESS and TEMPO

Potential applicants should keep in mind that applying to one program does not require application to the other, though FDA stated that it expects TEMPO participants’ devices to be offered to or by ACCESS participants. Therefore, when considering whether to apply to TEMPO and/or ACCESS, companies should consider the benefits of each separately and together. For digital health entities, such considerations often begin with understanding the product roadmap and overall regulatory framework for various software functions and digital health tools. ACCESS may also present benefits for provider groups not currently engaged in remote patient monitoring, but which can now consider whether use of digital health tools could qualify for reimbursement through ACCESS.

Particularly for new and emerging companies, the ability to commercialize digital health technologies without having to wait for FDA marketing authorization is a huge incentive for applying to TEMPO. That said, entities should not rush to participate in the program without first considering some key questions, such as:

1. Is your digital health technology a medical device under the Federal Food, Drug, and Cosmetic Act, 21 USC 321(h)(1), or is it not a medical device under the carve outs to that definition created by the 21st Century Cures Act?
2. What is your plan and market positioning for your digital health technology? How are your competitors marketed? Are they medical devices or medical devices that are already subject to FDA’s current enforcement discretion policies concerning “wellness products”?
3. Have you already engaged with FDA through pre-submission meetings? If so, have you aligned with the agency on a regulatory approach for your product?
4. Do you have FDA’s marketing authorization for any of your products? Do you have plans to modify your product with artificial intelligence or other technological enhancements? Are you looking to expand your indications to include one of the areas covered by ACCESS and TEMPO?
5. Are you looking to achieve enhanced reimbursement for your digital health technology?

Similarly, when considering whether to apply to ACCESS, companies should first think through their commercialization strategy, which builds from the above questions. For example, potential ACCESS applicants should consider the following before applying:

• Are you positioned to enroll directly in the Medicare program, or will you need to work via healthcare provider partners to offer your technology through ACCESS?
• Is your product otherwise eligible for reimbursement outside of the ACCESS program? For instance, is your digital health technology reasonable and necessary to deliver services already recognized under care management or remote patient monitoring codes?
• Are there features of your product or new products you are developing in areas that Medicare has not traditionally reimbursed, such as general wellness?

Cooley’s life sciences and healthcare regulatory team closely monitors these new programs and actively works with clients to think through these and related strategic regulatory questions. We are available to discuss the implications of these programs for your organization and advise on FDA requirements and healthcare compliance more generally. For assistance, please contact the authors listed below.

Cooley associate Regina DeSantis and law clerk Laura Wenzel also contributed to this alert.

The shooting happened Monday afternoon in the 12200 block of Vance Jackson Road

SAN ANTONIO – A person was detained after a man was shot Monday on the Northwest Side, according to the San Antonio Police Department.

The shooting happened just before 2 p.m. at The Jax Apartments located in the 12200 block of Vance Jackson Road near Huebner Road.

According to an SAPD preliminary report, the man suffered a gunshot wound. He was taken to a hospital with non-life-threatening injuries.

Additional information was not immediately available. SAPD said its investigation is ongoing.

This is a developing story. Check back for updates.

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Read also:

Copyright 2025 by KSAT – All rights reserved.

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DENVER, Dec. 15, 2025 /CNW/ – Ovintiv Inc. (NYSE: OVV) (TSX: OVV) (“Ovintiv” or the “Company”) and a subsidiary of Pembina Pipeline Corporation (“Pembina”) (TSX: PPL; NYSE: PBA) today announced the signing of a 12-year agreement (the “Agreement”) for 0.5 million tonnes per annum (“mtpa”) of Pembina’s liquefaction capacity at the Cedar LNG facility (“Cedar LNG”).

The Agreement enables the export of 0.5 mtpa of LNG, under which Pembina will provide transportation and liquefaction capacity to Ovintiv over a 12-year term, commencing with commercial operations at Cedar LNG, anticipated in late 2028. It provides Ovintiv, one of Canada’s largest natural gas producers, with access to additional export markets, complementary to the Company’s existing portfolio of natural gas transportation arrangements. Export from the west coast of Canada offers the shortest shipping distance to Asian LNG markets from North America.

“Today’s announcement marks a significant advancement in our strategy to expand market access and maximize the profitability of our Montney gas resource through participation in global LNG markets,” said Meghan Eilers, EVP of Midstream and Marketing at Ovintiv. “We are excited to partner with Pembina to supply low-cost Canadian natural gas to overseas markets, supporting energy security and global emissions reductions.”

Important information

Unless otherwise specified or the context otherwise requires, references to “Ovintiv,” “we,” “its,” “our” or to “the Company” includes reference to subsidiaries of and partnership interests held by Ovintiv Inc. and its subsidiaries.

Please visit Ovintiv’s website and Investor Relations page at www.ovintiv.com and investor.ovintiv.com, where Ovintiv often discloses important information about the Company, its business, and its results of operations.

ADVISORY REGARDING FORWARD-LOOKING STATEMENTS – This news release contains forward-looking statements or information (collectively, “forward-looking statements”) within the meaning of applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, except for statements of historical fact, that relate to the anticipated future activities, plans, strategies, objectives or expectations of the Company, including targets and initiatives, emissions reductions, expected access to additional LNG markets, and the anticipated timing of commencing with commercial operations at Cedar LNG, are forward-looking statements. When used in this news release, the use of words and phrases including “anticipate,” “strategy,” “will,” and other similar terminology are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words or phrases. Readers are cautioned against unduly relying on forward-looking statements which, are based on current expectations and by their nature, involve numerous assumptions that are subject to both known and unknown risks and uncertainties (many of which are beyond our control) that may cause such statements not to occur, or actual results to differ materially and/or adversely from those expressed or implied. These assumptions include, without limitation:  future commodity prices and global LNG demand; expectations of plans, strategies and objectives of the Company, including anticipated production volumes and capital investment; the outlook of the oil and natural gas industry generally, including impacts from changes to the geopolitical environment; the impact of changes in federal, state, provincial, local and tribal laws, rules and regulations, including the impact of changes in trade policies, tariffs, and interprovincial pipeline development and capacity; and projections made in light of, and generally consistent with, the Company’s historical experience and its perception of historical industry trends; and the other assumptions contained herein.

Although the Company believes the expectations represented by its forward-looking statements are reasonable based on the information available to it as of the date such statements are made, forward-looking statements are only predictions and statements of our current beliefs and there can be no assurance that such expectations will prove to be correct. All forward-looking statements contained in this news release are made as of the date of this news release and, except as required by law, the Company undertakes no obligation to update publicly; revise or keep current any forward-looking statements. The forward-looking statements contained or incorporated by reference in this news release, and all subsequent forward-looking statements attributable to the Company, whether written or oral, are expressly qualified by these cautionary statements.

The reader should carefully read the risk factors described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and in other filings with the SEC or Canadian securities regulators, for a description of certain risks that could, among other things, cause actual results to differ from these forward-looking statements. Other unpredictable or unknown factors not discussed in this news release could also have material adverse effects on forward-looking statements.

Further information on Ovintiv Inc. is available on the Company’s website, www.ovintiv.com, or by contacting:

SOURCE Ovintiv Inc.

Tampa International Airport and Cayman Airways on Monday celebrated 40 years of nonstop flights between Tampa Bay and the Cayman Islands with music, snacks and plenty of VIPs.

The airline began flying between TPA and Grand Cayman’s Owen Roberts International Airport (GCM) in 1985. Since then, Cayman Airways has become TPA’s longest-serving airline to the Caribbean region, which Airport CEO Michael Stephens said was a prime example of the close bonds the Tampa Bay region and the Cayman Islands have created over the last four decades.

“For the past 40 years, TPA and Cayman Airways have been forging a tremendous relationship that connects both people and cultures, and strengthens year after year,” Stephens said. “This relationship illustrates just how important working together has been, not only to our airport, but to the entire Tampa Bay community.”

TPA marked the anniversary with Caymanian music, traditional treats, giveaways and more in its Main Terminal and at Airside F. The entertainment included live performances by Stuart Wilson, a native Caymanian who traveled to Tampa for the event.

Also joining the festivities were members of the Caymanian Parliament, including Deputy Premier and Minister for Tourism and Trade Development Gary Rutty, who spoke at Monday’s departing flight about the ties between the islands and the city of Tampa. 

“For many Caymanians, including myself, Tampa has always been more than a destination – it is a familiar place where Caymanians have traveled for education, medical care, shopping and weekend getaways,” Rutty said. “For our Floridian friends, the Cayman Islands have become a favorite home away from home. Over the years, thousands of visitors from Tampa have discovered the beauty of our beaches, the warmth of our people and the unmistakable feeling of Cayman kindness found only within our shores.”

Capt. Kris Bergstrom, the Deputy Chairman of the Board of Directors for Cayman Airways, said he anticipated great things from the continued success of the Tampa to Grand Cayman route.

“Today, as we celebrate 40 years of service, we also celebrate the enduring relationship between Tampa and the Cayman Islands, one built on trust, history and mutual respect,” Bergstrom said. “As we look forward, we do so with confidence that this route will continue to serve as a bridge between our communities for many, many years to come.”

Nonstop flights are available five days a week, making Tampa Bay the destination with the second-highest number of flights among U.S. cities for Cayman Airways. About 17,000 visitors from the Tampa Bay catchment area visited the Cayman Islands over the past year.

If you’re thinking about making the short trip down to the Cayman Islands, click here to read TPA’s travelogue about Grand Cayman to learn more about all you can see and do while on island time. 

To celebrate this historic milestone, TPA and Cayman Airways have partnered to give away two roundtrip tickets and a stay at the Wyndham Reef Resort. The giveaway ends at 10 a.m. on Monday, Dec. 22, so enter today by clicking here: https://tpasweepstakes.wishpondpages.com/landing-page-2830739/

Click a photo below to enlarge or download it:

Ford Motor Company has ceased production of the all-electric F-150 Lightning, its flagship full-size electric pickup, and will focus instead on hybrid vehicles and a future line of smaller, cheaper EVs. Battery plants once intended to supply Ford trucks will now be sending batteries to bolster the electric grid instead.

Ford says the move is following customer demand, and reflecting the reality that the all-electric Lightning was a money-loser — and Ford, concluded, it always would be.

“The American consumer is speaking clearly and they want the benefits of electrification like instant torque and mobile power,” said Andrew Frick, the president of Ford Blue and Ford model e, the company’s commercial and electric divisions. He spoke to reporters on a call on Monday. “But they also demand affordability … rather than spending billions more on large EVs that now have no path to profitability, we are allocating that money into higher-returning areas.”

The Lightning’s design evolved from what was once a gas-powered truck. And now it will come full circle; an upcoming plug-in hybrid version of the truck will once again have a gasoline engine, in the form of a generator that will allow the vehicle to keep driving even if the battery runs out of juice. The all-electric Lightning is dead; the extended-range Lightning is on its way.

The all-electric F-150 Lightning was a big deal to Ford. It was announced in 2021 with great fanfare and an appealingly low price of just $40,000. But once it actually hit production lines, Ford was never able to sell it for anything close to the promised price tag; the 2025 model started at around $55,000.

The truck was designed to appeal to mainstream truck enthusiasts, with no quirky EV styling. It came festooned with outlets everywhere, leveraging the onboard battery so drivers could run tools at a worksite, power appliances at a tailgate party and even run their house on it, using it like a generator during a power outage.

The Lightning won 2023 Truck of the Year from Motortrend, unanimously, and from the North American Car, Utility and Truck of the Year Awards. It was Kelley Blue Book’s top pick for electric trucks in 2024. And it was the best-selling electric truck in America last quarter, Ford says.

But that category as a whole was struggling, as electric pickups failed to live up to lofty expectations — for performance and affordability, and as a result, for sales. The Lightning, in particular, struggled with reliability. Shoppers were turned off by its limited range when towing; why buy a truck that can’t do truck stuff? 

And, more to the point, Ford lost money on every vehicle, even at the higher-than-promised price point. EV sales have been lower than automakers had expected in the past few years. Production costs didn’t come down as much as Ford had hoped.

Meanwhile, the Trump administration has pulled a 180 on EV policy, eliminating incentives and requirements that pushed buyers and automakers alike toward electric vehicles.

That includes stripping away a $7,500 tax credit that had made some EVs more affordable, and removing emissions and fuel economy standards that gave Ford — among other EV makers — an incentive to keep unprofitable vehicles in production. Those rules, which required automakers to make their new vehicle fleets cleaner, on average, over time, are being dialed down — which means automakers can make more big gas- and diesel-powered trucks and fewer EVs without running afoul of federal regulations.

Frick said that “changes in the regulatory environment” were part of the “entire landscape” that pushed Ford to discontinue the vehicle and work on the extended-range version instead.

Meanwhile, Ford’s all-electric ambitions will be smaller — literally, with more compact and affordable vehicles at the heart of the company’s EV plans, starting with the midsize pickup truck the company announced in August. Ford is targeting a price point of $30,000 and expects to roll them out roughly a year from now.

The change in plans will cost Ford billions of dollars in write-offs and cash this year, but the company says it will make up for it by replacing a money-losing vehicle with ones it hopes will be profitable.

The pivot also leaves Ford with far more battery production capacity than it needs, since the company had invested heavily to build battery factories to supply the EV production lines that it’s now idling.

So it announced a new line of business: Ford will be revamping a battery production site in Kentucky to build batteries for stationary storage instead of for trucks. Those batteries can be sold to balance the electric grid — batteries can charge up when electricity is cheap, like when wind and solar are abundant, and discharge it when electricity is scarce, a phenomenon that’s already reshaping the electric grids in California and Texas.

They’ll also be sold to data centers and other industrial customers, Ford says.